LEan Body Mass Development in CriTically Ill Patients, Obtained by bioelectRical impEdance Analysis: a Combined Retrospective and Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 620
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
This study investigates how different methods of calculating protein intake affect recovery and muscle preservation in critically ill patients in the Intensive Care Unit (ICU). Protein is essential for maintaining muscle strength, supporting healing, and improving recovery during critical illness.
At Hospital Gelderse Vallei, patients admitted to the ICU received protein based on actual body weight until 2023; more recently, protein prescriptions have been based on fat-free mass. Bioelectrical impedance analysis (BIA) has been part of standard clinical practice in the ICU since April 2020, meaning that all patients admitted since then have been screened for inclusion in the study.
This design allows for comparison between two groups: one group receiving protein based on actual body weight according to current clinical guidelines (1.5 g/kg body weight), and another group whose protein intake is calculated based on lean body mass (LBM) measured by BIA. BIA measurements are repeated during the ICU stay to monitor changes in body composition.
A total of 310 patients admitted to the ICU between the start of BIA implementation in April 2020 and the transition to fat-free mass-based dosing in 2023 were identified. To allow for balanced comparison, an equal number of 310 patients from the subsequent period, in which protein dosing was based on fat-free mass, were included in the study.
The study compares these two groups to determine whether calculating protein requirements based on lean body mass leads to better clinical outcomes-such as improved recovery (lower mortality and shorter hospital stay), preservation of muscle mass, and lower UCR-than the traditional method based on actual body weight. The data analysis plan was established prior to completion of patient inclusion and database lock.
详细描述
Patients were enrolled through an opt-out procedure using an information leaflet included in the admission folder. The acquisition of informed consent from patients admitted between April 2020 and July 2023 was deemed neither necessary nor feasible, as the study relies on an anonymized database and no additional measurements are performed. Therefore, the internal committee for research evaluation approved the waiver of informed consent for these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •a BIA measurement available within 48 hours after ICU admission
- •at least one follow-up BIA measurement during ICU stay.
排除标准
- •transfer from another ICU resulting in the first BIA measurement >48 hours after admission to GVH
- •a previous ICU admission within 2 weeks before the current admission.
研究组 & 干预措施
ABW fed
This group received proteins based on 1.5 grams per kilogram actual body weight
FFM fed
This group received proteins based on 1.85 grams per kilogram fat free mass (BIA determined)
结局指标
主要结局
Mortality
时间窗: Mortality, defined as death from any cause, from ICU admission until 90 days post-admission
Short (ICU and 30-day mortality) and long-term mortality (90 days)
次要结局
- ICU and hospital length of stay(From ICU admission until the date of ICU discharge or the documented date of death from any cause, whichever comes first, assessed up to 52 weeks after ICU admission)
- Duration of invasive mechanical ventilation (IMV)(Number of days on invasive mechanical ventilation (IMV), defined as the total number of days with IMV from initiation until ICU discharge, assessed up to 52 weeks after ICU admission)
- Urea-creatinine ratio during ICU stay(All UCR measurements taken during the ICU stay, from ICU admission to ICU discharge, with each measurement recorded daily and specified by the day relative to ICU admission, up to a maximum of 52 weeks)
- Changes in BIA parameters over time (in kg)(All BIA measurements during the ICU stay, including dry fat-free mass, skeletal muscle mass and fat mass, recorded daily from ICU admission to ICU discharge, up to 52 weeks.)
- Changes in BIA water parameters over time (in L)(All BIA measurements during the ICU stay, such as intracellular water, extracellular water, and total body water, recorded daily from ICU admission to ICU discharge, up to 52 weeks)
- Changes in BIA phase angle(All BIA measurements during the ICU stay, such as phase angle, recorded daily from ICU admission to ICU discharge, up to 52 weeks)
研究者
ARH van Zanten, MD PhD
Principal Investigator
Gelderse Vallei Hospital